Analytical Development Scientist

We are looking for an Analytical Development Scientist to join our team on-site in Hopewell, NJ. This position involves performing routine analytical tests to support process development, transferring analytical methods to the QC department, and assisting in the development of analytical methods for biologic drugs. The ideal candidate will have experience in FDA-regulated biotechnology or pharmaceutical companies, proficiency in analytical chemistry or biology, and strong communication and problem-solving skills.

Responsibilities:

• Perform routine analytical tests (e.g., SEC, CE, ICIEF, Protein A) to support the upstream and downstream process development.
• Write SOPs, experimental methods, and reports.
• Support the development and transfer of analytical methods for biologic drugs (including monoclonal antibodies, bispecific antibodies, ADCs).
• Understand the CMC process of biologic drugs and operational specifications for QC and QA.
• Collaborate with applications to fulfill experiment requirements and compile reports.
• Assist in sample preparation, reagent management, and stable sample management.

Requirements:

• Previous experience in an FDA-regulated biotechnology or pharmaceutical company.
• CMCCP Certification preferred.
• Minimum/at least 2+ years working experience with a bachelor's or above in Biochemistry, Molecular biology, Biology, or Biotechnology-related scientific discipline.
• Proficiency in analytical chemistry or biology with a strong background in analyzing biological drug products (monoclonal antibodies, bispecific antibodies, ADCs) using techniques such as HPLC, UPLC, CE, and Elisa.
• Exceptional written and verbal communication skills, able to effectively communicate across all levels of the organization.
• Strong analytical and problem-solving abilities.
• Demonstrated ability to prioritize tasks and manage time effectively.
• Self-motivated with the initiative to work proactively.

Travel:

• Must be willing to travel approximately 10%
• Ability to work on a computer for extended periods of time